MAUDE Adverse Event Report: STRYKER GMBH HUMERAL CUP - 40MM DIA X 4MM THK; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number	5570-4004
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation revealed the baseplate, the peripheral screws, the humeral cup, the humeral insert, the glenosphere and the humeral stem to be the primary products.No further associated products were reported.A physical examination could not be carried out as the items were not received for evaluation (retained by the patient).A review of the device history records revealed no deviation in the manufacturing process.The items were documented as faultless prior to distribution.Thus, we excluded deviations in material and manufacturing.In the case presented a patient had been treated with a reunion reverse shoulder arthroplasty on (b)(6) 2016.On (b)(6) 2017 the patient had to be revised as the patient presented with instability.All implants were removed and replaced by new ones.Only the humeral stem was not exchanged.Further information such as medical records, x-rays, surgery reports or progress notes will not be available due to hospital policy.Thus a medical statement was not possible.The reported event could not be confirmed with the information given.A more precise evaluation was not possible.With available information a deficiency of the devices could not be verified.The file will be closed formally.In case relevant clinical information or the items should become available, we reserve the right to update the investigation and change the root cause.Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject products.Patient kept the device.
Event or Problem Description
As reported: "surgeon did original surgery.Patient presented with instability.Proceeded to revise all components other than stem.All new parts (reunion).Right shoulder - no other info per hospital policy.".

• Brand Name: HUMERAL CUP - 40MM DIA X 4MM THK
• Common Device Name: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• MDR Report Key: 6881219
• Report Number: 0008031020-2017-00546
• Device Sequence Number: 19137939
• Product Code: KWS
• UDI-Device Identifier: 07613327098389
• UDI-Public: 07613327098389
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K130895
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 5570-4004
• Device Lot Number: 9E4A9X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2017
• Initial Report FDA Received Date: 09/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 106